U.S. Cancer Patients Suffering From Drug Shortages

MONDAY, June 3 (HealthDay News) -- Four out of five U.S. cancer
doctors encountered shortages of essential drugs between March and
September of 2012, which affected the quality of care they provided
and increased treatment costs, new research shows.

The survey of 250 cancer doctors across the United States
reveals a medical community grappling with ongoing shortages of
needed medications, said lead author Dr. Keerthi Gogineni, a
medical oncologist in the Abramson Cancer Center and the Perelman
School of Medicine at the University of Pennsylvania in
Philadelphia.

About 94 percent of the doctors surveyed said the shortages had
an impact on patients' treatment, and 83 percent were unable to
provide standard chemotherapy. About 13 percent reported that
shortages interfered with clinical trials.

The findings were scheduled for presentation Monday at the
annual meeting of the American Society of Clinical Oncology in
Chicago.

American medicine has suffered significant drug shortages since
2006. President Barack Obama ordered the U.S. Food and Drug
Administration in October 2011 to take corrective measures after
prescription drug shortages hit an all-time high in the United
States, with around 200 medications reported in limited supply.

The FDA now requires drug manufacturers to report impending
shortages, and the agency has sped up its review of new
manufacturing sites and suppliers.

The drugs most commonly reported in shortage by survey
participants were leucovorin, liposomal doxorubicin,
5-fluorouracil, bleomycin and cytarabine. These drugs are commonly
used in the treatment of various forms of cancer, including
gastrointestinal, blood, breast, ovarian and testicular
cancers.

Cytarabine, which has been in use for four decades, is
particularly critical for the treatment of leukemia. "That drug is
the cornerstone of treatment for a common form of acute leukemia,"
said Dr. Len Lichtenfeld, deputy chief medical officer for the
American Cancer Society. "To not have that drug when you need it is
clearly problematic."

The survey found that cancer doctors have adapted to such
shortages in different ways:

78 percent switched treatment regimens.

77 percent substituted alternate drugs part way through
therapy.

43 percent delayed treatment.

37 percent had to choose which patients would receive the
available medication.

29 percent omitted doses from a chemotherapy regimen.

20 percent reduced the required dosage.

"Clearly, it impacts the treatments patients receive," Lichtenfeld said. "It takes a long time to develop an understanding of effective drug regimens. When you can't use a proven effective drug and you have to go to an alternative plan, you certainly become concerned about the effect of that switch on the health of your patient."

These shortages also have driven up the cost of care, Gogineni
added. Doctors unable to use well-known generic cancer drugs have
had to substitute more expensive brand-name medications for
patients in need. Oncologists surveyed said they substituted more
expensive branded drugs 60 percent of the time when confronted with
shortages in the generic medications 5-fluorouracil, leucovorin and
paclitaxel.

For example, the cost of one round of colon cancer treatment
using 5-fluorouracil is about $28, Gogineni said. Almost
one-quarter of the doctors surveyed said they had to resort to a
brand-name alternative, capecitabine, which costs $3,900 for one
round of treatment.

"The shortages that we see in cancer drugs are in the cheaper generic agents," she said. "It's rare for a branded agent to be in shortage."

More than two-thirds of care providers surveyed said they had no
institutional guidelines or committee to help make difficult
decisions regarding treatment modification.

Gogineni said she would like to see organizations such as the
American Society of Clinical Oncology begin issuing "best practice"
guidelines to help doctors best deal with known or anticipated drug
shortages.

"When we know there's a drug that's going to be in shortage, it would be relatively straightforward for us to issue guidelines for what's the next best practice," she said.

A separate study conducted by the society and also presented at
the annual meeting echoes Gogineni's survey findings. The ASCO
survey found that nearly 60 percent of physicians surveyed were
aware of ongoing drug shortages in the community. More than 40
percent said the shortages have not been resolved.

Lichtenfeld said he hopes the findings will renew public
attention regarding this ongoing issue.

"We had substantial interest in this topic a while ago, starting in 2011, but you don't hear as much about it today as you did then," he said. "The problem remains very real, and this study might refocus our attention on what remains a serious issue for cancer patients and those who care for them."

Data and conclusions presented at meetings should be considered
preliminary until published in a peer-reviewed medical journal.

Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.